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临床试验/NCT01265277
NCT01265277已完成不适用

Changes in Sleep Patterns and Stress in Infants Entering Child Care: Implications for SIDS Risk

Rachel Moon, MD1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Sleep efficiency

研究概览

简要总结

When babies start day care, they experience many changes, some of which may affect their risk for sudden infant death syndrome (SIDS). The investigators want to find out if stress or change in the baby's sleep patterns can be a reason for this increased risk for SIDS.

详细描述

The overall aim of this study is to describe sleep patterns in infants as they transition from home to child care, including 24-hour sleep duration, changes in the timing of daytime naps, and changes in nocturnal sleep periods; to describe potential sleep disrupters, such as temperature, light and noise, in home and child care settings that may impact sleep quality and sleep patterns; to describe markers of parent and infant stress levels during the transition to child care; to describe markers of infant circadian rhythm during the transition to child care.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants who are less than 3 months of age from English-speaking families where one or both parents live in the household will be eligible to participate. If the infant will be entering child care, the infant must be entering a licensed child care center, and child care entry must be between 60 and 120 days of age.

排除标准

  • S/he was born prematurely, with a gestational age less than 37 weeks at birth, or had a birth weight <2500 grams (5-1/2 lbs)
  • S/he has any medical problems that require ongoing care by a subspecialty physician

结局指标

主要结局

Sleep efficiency

时间窗: Days -14 through +14

sleep efficieny is defined as the ratio of time spent asleep (total sleep time) to the amount of time spent in bed.

次要结局

  • Sleep duration(Days -14 to +14)

研究者

发起方
Rachel Moon, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rachel Moon, MD

MD

University of Virginia

研究点 (1)

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